MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-07-26 for RINGLOC 10 DEGREE TRIAL LINER 3/8" SCREW SIZE 24 X 36MM ID N/A 33-117844 manufactured by Biomet Orthopedics.
[18123096]
It was reported that patient underwent hip arthroplasty procedure in (b)(6) 2011. During the procedure, after impaction of the acetabular cup, the surgeon inserted the trial liner and after fixating the liner to the cup he noted that the screw portion had separated from the trial liner. The surgeon removed the screw from the bottom of the cup and continued with the procedure. There was no injury to the patient or delay in the procedure as a result.
Patient Sequence No: 1, Text Type: D, B5
[18452158]
Review of device history records show that lot released with no recorded anomaly or deviation. Date of event: (b)(6) 2011, exact date unknown. Evaluation of the returned component found evidence to suggest that it failed via a push-out overload of the fastener through the apical hole of the provisional liner. The user facility was notified of the event on (b)(6), 2011. To date, a response has not been received from the user facility. In the event that the user facility submits a medwatch report, biomet will forward a copy to the fda. This report filed (b)(4), 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2011-00632 |
| MDR Report Key | 2179320 |
| Report Source | 07 |
| Date Received | 2011-07-26 |
| Date of Report | 2011-06-29 |
| Date Mfgr Received | 2011-06-29 |
| Device Manufacturer Date | 2010-06-02 |
| Date Added to Maude | 2011-08-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. CRAIG BUCHMAN |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5743711132 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RINGLOC 10 DEGREE TRIAL LINER 3/8" SCREW SIZE 24 X 36MM ID |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2011-07-26 |
| Returned To Mfg | 2011-06-29 |
| Model Number | N/A |
| Catalog Number | 33-117844 |
| Lot Number | 21443551 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 EAST BELL DRIVE P.O. BOX 587 WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-26 |